Rehabilitation for Head and Neck Cancer
2020年4月28日 更新者：Norwegian University of Science and Technology
Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial
Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss.
More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life.
Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting.
The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT).
Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT.
Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
41
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Røros、挪威、7374
- LHL-klinikkene Røros
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Trondheim、挪威
- St Olavs hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of squamous cell cancer (SCC) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity)
- Due to commence curative radiotherapy (RT) or chemoradiotherapy (CRT)
- All baseline assessments can be completed within 4 weeks prior to first cycle of RT or CRT
- Written informed consent is present
- willing to comply with study procedures
Exclusion Criteria:
- stage T1N0M0 laryngeal cancer
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Early rehabilitation
Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.
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The intervention consists of physical exercise, nutritional counselling and supplements.
The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT).
The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions.
The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily.
A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period.
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有源比较器：Late rehabilitation
Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education
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The intervention consists of physical exercise, nutritional counselling and supplements and patient education.
The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT).
PRT will be conducted as described in the intervention during treatment.
The nutritional intervention will be carried out as described in the intervention during treatment.
Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.
大体时间：15 weeks
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15 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3
大体时间：15 weeks
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15 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Stein Kaasa, prof MD、Norwegian University of Science and Technology
- 首席研究员：Jo-Åsmund Lund, MD PhD、St. Olavs Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sandmael JA, Bye A, Solheim TS, Stene GB, Thorsen L, Kaasa S, Lund JA, Oldervoll LM. Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot randomized trial. Cancer. 2017 Nov 15;123(22):4440-4448. doi: 10.1002/cncr.30901. Epub 2017 Jul 31.
- Sandmael JA, Bye A, Solheim TS, Balstad TR, Thorsen L, Skovlund E, Kaasa S, Lund JA, Oldervoll L. Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program. Laryngoscope Investig Otolaryngol. 2020 Mar 17;5(2):330-338. doi: 10.1002/lio2.368. eCollection 2020 Apr.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年4月1日
初级完成 (实际的)
2017年4月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2015年4月22日
首先提交符合 QC 标准的
2015年5月6日
首次发布 (估计)
2015年5月12日
研究记录更新
最后更新发布 (实际的)
2020年4月30日
上次提交的符合 QC 标准的更新
2020年4月28日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.